Biblioteca Hospital 12 de Octubre

First-line response-adapted treatment with the combination of bendamustine and rituximab in patients with mucosa-associated lymphoid tissue lymphoma (MALT2008-01): a multicentre, single-arm, phase 2 trial. (Registro nro. 16287)

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Campo de control de longitud fija nab a22 7a 4500
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Campo de control PC16287
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Campo de control 20210406121944.0
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Centro transcriptor H12O
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100 ## - PUNTO DE ACCESO PRINCIPAL - NOMBRE DE PERSONA
9 (RLIN) 1482
Nombre de persona Grande García, Carlos
Término indicativo de función Hematología y Hemoterapia
245 00 - MENCIÓN DE TÍTULO
Título First-line response-adapted treatment with the combination of bendamustine and rituximab in patients with mucosa-associated lymphoid tissue lymphoma (MALT2008-01): a multicentre, single-arm, phase 2 trial.
Tipo de material [artículo]
260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT)
Nombre del editor distribuidor etc. The Lancet. Haematology,
Fecha de publicación distribución etc. 2014
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Extensión 1(3):e104-11.
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Nota general Formato Vancouver:
Salar A, Domingo-Domenech E, Panizo C, Nicolás C, Bargay J, Muntañola A et al; Grupo Español de Linfomas/Trasplante de Médula Ósea (GELTAMO). First-line response-adapted treatment with the combination of bendamustine and rituximab in patients with mucosa-associated lymphoid tissue lymphoma (MALT2008-01): a multicentre, single-arm, phase 2 trial. Lancet Haematol. 2014 Dec;1(3):e104-11.
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Nota de "Con" PMID: 27029228
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Nota de bibliografía etc. Contiene 30 referencias
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Sumario etc. Background: No standard first-line systemic treatment for mucosa-associated lymphoid tissue (MALT) lymphoma is available. In a phase 2 study we aimed to assess the safety and activity of a response-adapted combination of bendamustine plus rituximab as upfront treatment for this type of lymphoma.
Methods: In a multicentre, single-arm, non-randomised, phase 2 trial, we enrolled patients with MALT lymphoma at any site and stage and treated them with bendamustine (90 mg/m(2) on days 1 and 2) plus rituximab (375 mg/m(2) on day 1), every 4 weeks. Inclusion criteria were measurable or evaluable disease, age 18-85 years, and unequivocal active lymphoma; we also enrolled patients with MALT lymphoma arising in the stomach after failure of Helicobacter pylori eradication and primary cutaneous cases after failure of local therapies. Exclusion criteria included evidence of histological transformation, CNS involvement, and active hepatitis B or C virus or HIV infection. After three cycles, patients achieving complete response received one additional cycle (total four cycles) and those achieving partial response received three additional cycles (total six cycles). The primary endpoint was 2-year event-free survival. Analysis was by modified intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01015248.
Findings: 60 patients from 19 centres in Spain were enrolled between May 27, 2009, and May 23, 2011, and received treatment; 57 patients were evaluable for the primary endpoint. Only 14 (25%) patients needed more than four cycles of treatment. After a median follow-up of 43 months (IQR 37-51), median event-free survival was not reached. Event-free survival at 2 years was 93% (95% CI 84-97) and at 4 years was 88% (95% CI 74-95). The most frequently observed grade 3-4 adverse events were haematological: lymphopenia in 20 (33%) patients, neutropenia in 12 (20%) patients, and leucopenia in three (5%) patients. Grade 3-4 febrile neutropenia or infections were reported in three (5%) and four (7%) patients, respectively.
Interpretation: This response-adapted schedule of bendamustine plus rituximab appears to be an active and well tolerated first-line treatment for patients with MALT lymphoma.
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9 (RLIN) 297
Nombre de entidad o nombre de jurisdicción como elemento inicial Servicio de Hematología y Hemoterapia
856 ## - LOCALIZACIÓN Y ACCESO ELECTRÓNICOS
Identificador Uniforme del Recurso (URI) http://pc-h12o-es.m-hdoct.a17.csinet.es/pdf/pc/1/pc16287.pdf
Acceso Solicitar documento
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          Hospital Universitario 12 de Octubre Hospital Universitario 12 de Octubre 2021-02-23 PC16287 2021-02-23 2021-02-23 Artículo

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